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NCT Number: NCT03470675

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS.

This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS.

The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.

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Key information

Conditions

Pain Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Postpartum Depression Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years of age
  • English-speaking
  • Vaginal delivery (spontaneous or assisted)
  • A full-term fetus (>37 weeks' gestation)
  • OASIS as assessed by obstetrical provider
  • Functional epidural analgesia at time of delivery
  • Patient amenable to follow-up in specialty perineal clinic within the first week postpartum

Exclusion criteria

  • Previous pelvic surgery
  • History of chronic pelvic pain
  • History of recurrent urinary tract infections
  • Women with known malformations of their urinary tract
  • True allergies to ketamine and/or morphine
  • Preeclampsia or hypertensive disorder at the time of delivery
  • Obstructive sleep apnea

Treatment and study plan

Epidural saline + IV saline

Drug

Sterile saline injection in the epidural catheter and in the intravenous catheter

Epidural morphine 3 mg + IV saline

Drug

Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter

Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

Drug

Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter

Primary outcomes

  1. Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.

    Time frame: 1 week after vaginal delivery

    Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good)and 10 highest pain (poor).

Secondary outcomes

  1. Perineal Pain

    Time frame: Day 1 after delivery

    Perineal pain day 1 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.

  2. Perineal Pain

    Time frame: 1 week after delivery

    Perineal pain day 7 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.

  3. Assessment of Maternal-infant Bonding

    Time frame: 1 week after delivery

    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment (poor) to 95 high maternal infant attachment (good).

  4. Presence of Postpartum Depression

    Time frame: 1 week after delivery

    Presence of postpartum depression 7 days after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low- 30 high. High scores indicate potential for depression.

  5. Brief Pain Inventory (BPI-ST Short Form) Current Pain

    Time frame: 1 week after delivery

    Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

  6. Presence of Postpartum Depression

    Time frame: 6 weeks after delivery

    Presence of postpartum depression 6 weeks after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.

  7. Perineal Pain

    Time frame: 6 weeks after delivery

    Perineal pain 6 weeks after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.

  8. Assessment of Maternal-infant Bonding

    Time frame: 6 weeks after delivery

    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.

  9. Brief Pain Inventory (BPI-ST Short Form) Current Pain

    Time frame: 6 weeks after delivery

    Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

  10. Perineal Pain

    Time frame: 3 months after delivery

    Perineal pain 3 months after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.

  11. Assessment of Maternal-infant Bonding

    Time frame: 3 months after delivery

    Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.

  12. Female Sexual Function

    Time frame: 3 months after delivery

    Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function to 36 high sexual function.

  13. Brief Pain Inventory (BPI-ST Short Form) Current Pain

    Time frame: 3 months after delivery

    Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.

  14. Promis 29 Profile (Physical Function Question Only)

    Time frame: 3 month

    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher physical function.

  15. Promis 29 Profile (Anxiety Function Question Only)

    Time frame: 3 month

    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 anxiety rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher anxiety.

  16. Promis 29 Profile (Depressive Symptoms Question Only)

    Time frame: 3 month

    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher depression.

  17. Promis 29 Profile (Fatigue Question Only)

    Time frame: 3 month

    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of fatigue.

  18. Promis 29 Profile (Sleep Disturbance Question Only)

    Time frame: 3 month

    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of sleep disturbance.

  19. Promis 29 Profile (Social Function Question Only)

    Time frame: 3 month

    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of social function.

  20. Promis 29 Profile (Pain Interference Question Only)

    Time frame: 3 month

    29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates a higher level of pain interference.

  21. Perineal Pain

    Time frame: 1 year after delivery

    Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good) and 10 highest pain (poor).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2018
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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